Identity
- Trade Name
- femometer FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, reagent FDA UDI
- Device Name
- This product is a rapid, one-step, visual test for the qualitative detection of follicle stimulating hormone (FSH) in human urine. It is intended for self-testing. It is to be used as a confirmation of body hormone changes related to the symptoms associated with the changes of menopause and as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful. FDA UDI
- Model / Reference
- FM-IVY-104 FDA UDI
- Description
- This product is a rapid, one-step, visual test for the qualitative detection of follicle stimulating hormone (FSH) in human urine. It is intended for self-testing. It is to be used as a confirmation of body hormone changes related to the symptoms associated with the changes of menopause and as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972412612000 FDA UDI
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, reagent FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Follicle stimulating hormone (FSH) IVD, reagent
femometer by Hangzhou Laihe Biotech Co., Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
Sources (1)
- FDA UDI cb0f40a9-fd59-4eb3-8fa8-0f17d9da56e4 33 fields · synced Jun 6, 2026